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Ensure implementation and oversight of the GCP Quality Management System (QMS) for clinical development activities in China, aligned with global standards and regulatory requirements, while driving digital and AI-related initiatives.
Job Responsibility:
Implement GCP QMS strategy locally
maintain Level 1 GCP quality documents
Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement
Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles
Ensure inspection readiness and manage regulatory inspections with cross function
Serve as primary contact for audit response management as needed
Develop and execute Vendor Quality Plans
monitor vendor compliance
Drive remediation strategies for vendor quality issues and ensure timely resolution
Promote GCP quality culture across teams and vendors
Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement
Actively contribute to digital and AI initiatives in China, including STRAT projects
Support AI-enabled Site Start-Up (SSU), participant recruitment, eSource, Care anywhere initiatives, and data analysis
Collaborate with global and local teams to implement AI-driven solutions for quality improvement and operational efficiency
Engage with internal and external experts to monitor trends and implement best practices